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First Xolair Biosimilar Approved, But Not Yet Launched

First Xolair Biosimilar Approved, But Not Yet Launched hero image

On March 7, 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Omlyclo® (omalizumab-igec) as the first interchangeable biosimilar to Novartis’ Xolair® (omalizumab). Omlyclo is approved for the same indications as ...

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize hero image

The US Food and Drug Administration (FDA) has determined the shortage of glucagon-like peptide 1 (GLP-1) medication, semaglutide, is resolved. Semaglutide injection products have been on the FDA shortage list since 2022. The FDA ...

Task Force Issues Final Recommendation on PrEP for HIV Prevention

Task Force Issues Final Recommendation on PrEP for HIV Prevention hero image

The 2023 United States Preventive Services Task Force (USPSTF) recommendation for PrEP specifically cites the three medications currently approved by the FDA for use as PrEP. Therefore, it is the position of The Departments, as outlined in FAQ…

FDA Announced Removal of Tirzepatide from the Drug Shortage List

FDA Announced Removal of Tirzepatide from the Drug Shortage List hero image

Doctors and pharmacists are allowed to compound drugs for individual patients when the compounded drug is not commercially available. Licensed outsourcing facilities (LOF) can compound at a higher volume but can only do so in…

2024 Trend Recap

2024 Trend Recap hero image

Notable industry trends throughout 2024 include the continued growth of the specialty market. Across the industry, specialty medications now account for an estimated 54% of spending which has been driven mainly by…

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